Comparison of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP and IPV Separately Administered Vaccines in Terms of Immune Response and Safety

Tetanus Clinical Trial

Official title:

Open, Randomized, Phase II, Clinical Trial to Compare the Immunogenicity and Safety of a Booster Dose of GSK Biologicals' DTaP-IPV Vaccine (Infanrix®-IPV) Co-administered With a Booster Dose of Merck and Company's M-M-R®II, to That of Separate Injections of GSK Biologicals' DTaP Vaccine (Infanrix®), Aventis Pasteur's IPV (IPOL®) and M-M-R®II Administered as Booster Doses to Healthy Children 4 to 6 Years of Age.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00263692
• Other study ID #: 213503/047
• Status: Completed
• Phase: Phase 2
• First received: December 8, 2005
• Last updated: September 14, 2016
• Start date: November 2002
• Est. completion date: September 2004

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The aims of this study are to compare the immunogenicity and safety of the GSK Biologicals' combined DTaP-IPV vaccine with separate administration of DTaP and IPV vaccines, when administered as a fifth dose of acellular pertussis vaccine to children aged 4 to 6 years when co-administered with MMR vaccine in subjects who had previously received four doses of Infanrix, three doses of poliovirus-containing vaccine and MMR vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: September 2004
• Est. primary completion date: September 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 6 Years

Eligibility

Inclusion Criteria:

• Healthy children between and including 4 and 6 years of age.

• Previously received 4 doses of GSK Biologicals' DTaP, 3 doses of IPV vaccine and 1 dose of measles, mumps, and rubella vaccine.

Exclusion Criteria:

• Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period.

• Chronic administration or planned administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period

• Administration of immunoglobulins and/or blood products within 3 months prior to vaccination.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acellular Pertussis
• Diphtheria
• Tetanus

Intervention

Biological:
• Prophylaxis: Diphtheria, tetanus, pertussis, poliovirus type 1, type 2 and type 3

Locations

Country	Name	City	State
United States	GSK Investigational Site	Berlin	New Jersey
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Endwell	New York
United States	GSK Investigational Site	Fountain Valley	California
United States	GSK Investigational Site	Jonesboro	Arkansas
United States	GSK Investigational Site	Marietta	Georgia
United States	GSK Investigational Site	Mechanicsville	Virginia
United States	GSK Investigational Site	New Orleans	Louisiana
United States	GSK Investigational Site	Oakland	California
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Ruston	Louisiana
United States	GSK Investigational Site	Stony Brook	New York
United States	GSK Investigational Site	Torrance	California
United States	GSK Investigational Site	Whitehouse Station	New Jersey
United States	GSK Investigational Site	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (2)

Black S, Friedland LR, Schuind A, Howe B; GlaxoSmithKline DTaP-IPV Vaccine Study Group. Immunogenicity and safety of a combined DTaP-IPV vaccine compared with separate DTaP and IPV vaccines when administered as pre-school booster doses with a second dose of MMR vaccine to healthy children aged 4-6 years. Vaccine. 2006 Aug 28;24(35-36):6163-71. Epub 2006 Apr 21. — View Citation

Weston WM, Klein NP. Kinrix: a new combination DTaP-IPV vaccine for children aged 4-6 years. Expert Rev Vaccines. 2008 Nov;7(9):1309-20. doi: 10.1586/14760584.7.9.1309. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity after vaccination.
Secondary	Immunogenicity and safety after vaccination.

External Links

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